FDA guidelines make way for Asian firms in US biosimilars market

"Regulators need to recognize that many of the products currently marketed as biosimilars are technically not biosimilars because they do not meet the comparability criteria with the originator molecules. Achieving comparability is a highly complex and resource-intensive process that takes many years of development," he adds.

Dr Harish Iyer, CEO of India-based Shantha Biotech, opines, "These guidelines that seem quite broad are a first step in the direction of defining a regulatory pathway for biosimilars in the US. The EU appears further ahead with specific guidelines for multiple categories of products, such as insulin, EPOs and GCSFs. I believe that most companies in Asia are following the European Medicines Agency (EMA) guidelines that were issued in 2004 to decide their development strategy. Several biosimilars developed in Europe have already been approved using these EMA pathways."

Quintiles suggests that companies seeking entry or having a sustained position within the biosimilars marketplace must first identify the requisite regulatory stipulations for every intended market. As guidelines and pathways around the world continue to mature, the complexity of this exercise cannot be understated. This process needs to follow a logical step-wise progression to ensure that a global development plan can be leveraged to satisfy regulators in each potential market. Should a single development plan not appear feasible, a decision must be made whether to undertake a bridging program for the market concerned; or, alternatively, improve the product and develop it as a biobetter. Successful biosimilars companies will be those who collapse their clinical, commercial and regulatory thinking into a streamlined cohesive function and embrace the organizational change that such a framework necessitates.